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NCT04039347: BOSTON-3
Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)
Phase 3 trial testing Liposomal Cyclosporine A 5 mg in Bronchiolitis Obliterans in 164 participants. Terminated before completion.
25 February 2026
Quick facts
| Lead sponsor | Zambon SpA |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 164 |
| Start date | 12 March 2020 |
| Primary completion | 25 February 2026 |
| Estimated completion | 25 February 2026 |
| Sites | 37 locations across France, Denmark, Belgium, Austria, United Kingdom, Germany, Israel, United States |
Drugs / interventions tested
- Liposomal Cyclosporine A 5 mg — full drug profile →
- Liposomal Cyclosporine A 10 mg — full drug profile →
Conditions studied
- Bronchiolitis Obliterans — all drugs for Bronchiolitis Obliterans →
- Obliterative Bronchiolitis — all drugs for Obliterative Bronchiolitis →
- Bronchiolitis Obliterans Syndrome — all drugs for Bronchiolitis Obliterans Syndrome →
Sponsor
Zambon SpA — full company profile →
Who can join
18 and older, any sex, with Bronchiolitis Obliterans or Obliterative Bronchiolitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Bronchiolitis obliterans syndrome after lung or haematopoietic stem cell transplantation: current management and future directions.
Glanville AR, Benden C, Bergeron A, Cheng GS, et al · · 2022 · cited 36× · PMID 35898810 · DOI 10.1183/23120541.00185-2022 -
Advancing Medicine with Lipid-Based Nanosystems-The Successful Case of Liposomes.
Luiz H, Oliveira Pinho J, Gaspar MM. · · 2023 · cited 27× · PMID 36830971 · DOI 10.3390/biomedicines11020435 -
Lymphocyte Depleting and Modulating Therapies for Chronic Lung Allograft Dysfunction.
Bos S, Pradère P, Beeckmans H, Zajacova A, et al · · 2023 · cited 5× · PMID 37295951 · DOI 10.1124/pharmrev.123.000834
Verify or expand the search:
- PubMed search for NCT04039347
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bronchiolitis Obliterans
Currently open trials in the same condition.
- NCT07316829 — TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejection: Correlation With Re · active not recruiting
- NCT05922761 — BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) · Phase 2 · recruiting
- NCT04604522 — Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome · recruiting
Other Zambon SpA trials
Trials by the same sponsor.
- NCT06503770 — A Retrospective Chart Review Study of Patients With Chronic Lung Allograft Dysfunction-Bronchiolitis Obliterans Syndrome · completed
- NCT03887221 — A Single and Multiple Dose Study to Assess How the Drug Enters, Moves Through and Exits the Body, Safety and Tolerabilit · Phase 1 · completed
- NCT04107675 — A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4) · Phase 2 · terminated
- NCT04229303 — Phase 1 Three Part SAD, MAD & Cross-Over Study of ZP-059 in Healthy and Asthmatic Subjects · Phase 1 · completed
- NCT03994328 — An Observational Study on Safinamide, Rasagiline and Other Standard of Care in PD · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04039347 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zambon SpA
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04039347.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing